Understanding CLIA '88 Regulations for Laboratory Safety and Quality

1. Chapter 38 Regulatory Guidelines for Safety and Quality in the Medical Laboratory

2. CLIA ’88 • Designed to set safety policies and procedures that protect patients • 1967: misread Pap smears caused Congress to become more involved with regulating laboratories (CLIA ’88) • States can seek exemptions if they have regulations comparable

3. CLIA ’88 • The intention of CLIA ’88 • Protect public by regulating all laboratory tests performed on humans • Based on complexity of tests performed • Affects all aspects of the laboratory • Type of test performed, personnel involved in testing, quality control

4. CLIA ’88 • General program description • CLIA is user-fee funded • More complicated the test, the more stringent the requirements • CMS charged with implementation of CLIA • CDC responsible for test categorization and CLIA studies

5. CLIA ’88 • General program description • To enroll in CLIA program, laboratories must register • Since CLIA, total number of quality deficiencies has decreased significantly

6. CLIA ’88 • Categories of testing • Waived tests • Simple, unvarying, require minimum of judgment and interpretation • Moderate-complexity tests • Provider performed microscopy: PPM procedures (also called PPMP) • High-complexity tests

7. CLIA ’88 • Contents of the law • List of analytes on the CLIA ’88 waived list • Criteria for PPMP • Criteria for CLIA waived tests

8. CLIA ’88 • CLIA ’88 Regulation for Quality Control in Automated Hematology • Required procedures • Calibration • Control samples • Proficiency testing • Check manufacturer’s recommendations for particular piece of equipment

9. CLIA ’88 • Aftermath of CLIA ’88 • Has led to concerns about overload of paperwork it produces • Developments regarding postponements and funding problems • Category of PPMP added as another certificate • Lower revenue than had been expected

10. CLIA ’88 • Impact of CLIA on medical assistants • Law covers all laboratories • Performing tests and maintaining personnel records • Documentation by MAs important • Responsibility of MAs to teach and assist others who may not be trained • MAs must know and comply with the law and be prepared for a CLIA inspection

11. CLIA ’88 • Where to find more information regarding CLIA ’88 • Guidelines available from Federal Register and online for a fee

12. OSHA Regulations • To ensure employers have safe and healthy work environment for employees • Applies to all workers, not just health care workers • State standards required to be as strict or greater than federal OSHA standards

13. OSHA Regulations • Standard for Occupational Exposure to Hazardous Chemicals in the Laboratory • Employee awareness of risks linked with chemical dangers • Employee training and identification of hazardous chemicals • Use of protective equipment

14. OSHA Regulations • Chemical Hygiene Plan (CHP) • Core of OSHA safety standard on hazardous chemicals • Written plan specifies training and information requirements of standard • Inventory taken

15. OSHA Regulations • Chemical Hygiene Plan (CHP) • List compiled of all chemicals considered hazardous • Material Safety Data Sheet (MSDS) manual assembled • Employer required to provide hazard communication educational program

16. OSHA Regulations • Requirements of Chemical Hygiene Plan • Written plan relevant to safety and health of employees • Written instructions on use of PPE • Fume hoods or biohazard hoods checked regularly • Training sessions must be held for employees

17. OSHA Regulations • Requirements of Chemical Hygiene Plan • Employer’s legal responsibility to provide medical attention • Employer responsibility for training sessions, manuals current, documentation • Instruction regarding disposal of hazardous waste • Written record of safety training

18. OSHA Regulations • Importance of chemical standards to medical assistants • All employees must comply or face penalties • All employees have right to know and be given information and educated regarding chemical hazards they are exposed to in place of employment

19. OSHA Regulations and Students • Students do not fall under the OSHA guidelines but should take precautions • Students may come into contact with harmful chemicals when doing procedures • Student safety laboratory manual should be assembled

20. Cumulative Trauma Disorders • Ergonomics is the study of the workplace • Cumulative trauma disorders: injuries involving musculoskeletal or nervous system • Result of long-term, repetitive work actions